Interest of Functional Neuroimaging in Assessing Decision-making Capacity of Older People With Neurocognitive Disorders (IMAGISION)

Feasibility Study of the Interest of Functional Neuroimaging in Assessing Decision-making Capacity of Older People With Neurocognitive Disorders

IMAGISION aims to explore, in a cohort of patients referred for geriatric consultation for neurocognitive evaluation, the contribution of functional neuroimaging (functional MRI and, if possible, high resolution EEG) to geriatric expertise, associated with the performance of a battery of neuropsychological tests in the evaluation of decision-making capacity.

Study Overview

• Status: Recruiting
• Conditions: Dementia; Aging; Decision Making
• Intervention / Treatment: Diagnostic test: Geriatric Assesment with neuropsychological test more specific on decision making; Diagnostic test: Functional RMI; Diagnostic test: High Resolution EEG; Other: Qualitative interview

Detailed Description

It is during aging of patients, especially those with polypathological disorders and in whom cognitive disorders appear, that the most complex and ethical questions arise. In this context, these patients are frequently referred to geriatric consultations or memory centres for a global assessment of their cognitive functions and life skills in order to optimize their care and anticipate their medical and medico-social future. The assessment of decision-making capacity is essential in this regard.

Nevertheless, there is no test that specifically explores this issue and, therefore, people's decision-making abilities may not be properly estimated and may prevent some patients from making decisions when they would be able to do so.

Thus, although the issue of decision-making has generally been explored from a neuropsychological perspective in many studies, there is no specific test or score for decision-making capacity, as it is a complex process. The question of decision-making capacity in complex situations is therefore addressed by a multiple analysis of many parameters, including different neuropsychological data, which are then synthesized by the clinician in a standardized geriatric assessment to get an idea, among other things, of the overall ability to make decisions.

Given the difficulty of this and the ethical and societal issue, the research question focuses on the contribution of neuroimaging technologies to the assessment of decision-making capacity.

In fact, several studies have explored the issue as part of the functional neuroimaging study. The investigators note, in particular:

• Decision-making studies were conducted using the EEG-High Resolution (EEG-HR) technique. It is a technique for electromagnetic analysis of brain functions with excellent temporal resolution and quite good spatial resolution. This allows, during functional decision tests, a detailed analysis of the temporality of the activation of the frontal and prefrontal areas.
• Functional MRI (fMRI) is a neurological imaging technique whose main strength lies in its spatial acuity. Thus, the performance of functional decisional tests under functional MRI allows a detailed analysis of the recruitment of the different zones between the dorsolateral prefrontal cortex and the median ventromedian cortex.

These 2 neuroimaging techniques allowed a neuro-functional analysis of decision making, based on the realization of more specific tests, modelling decision making. Among these models, the Iowa Game Task and the Balloon Assessement Risk Task are frequently used.

Nevertheless, all these tests and explorations were conducted independently, and no studies have investigated the contribution of a neurofunctional approach to patient decision-making through complementary explorations in functional MRI and /or in EEG-HR as diagnostic tools as part of an overall gerontological evaluation of decision making ability.

The question that arises is therefore that of the development of diagnostic tools.

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas TANNOU, MD; Phone Number: +33381669003; Email: ttannou@chu-besancon.fr
• Study Contact Backup: Name: Aurelie MARCEAU, PhD; Phone Number: ++33677132916; Email: amarceau@chu-besancon.fr

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3W1W6
      • Recruiting
      • CRIUGM
      • Contact: Thomas TANNOU, MD; Phone Number: +15143403540; Email: thomas.tannou@umontreal.ca
      • Contact: Sven JOUBERT, PhD; Phone Number: +15143403540; Email: sven.joubert@umontreal.ca
      • Principal Investigator: Sven JOUBERT, PhD
• France
  • BFC
    • Besancon, BFC, France, 25000
      • Recruiting
      • Centre Hospitalier Universitaire de Besançon
      • Contact: Thomas TANNOU, MD; Phone Number: +33381669003
      • Principal Investigator: Thomas TANNOU, MD
      • Sub-Investigator: Eloi MAGNIN, MD-PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• French speaker
• Recent diagnosis of neurocognitive disorder
• Agreed with the study

Exclusion Criteria:

• Delirium
• Major depressive symptoms
• MRI contraindication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; After first consultation for diagnosis of neurodegenerative disorder : Geriatric Assessment with specific neuropsychologic tests of decision making; fRMI; EEG High Resolution; Qualitative interview

Diagnostic test: Geriatric Assesment with neuropsychological test more specific on decision making; The following tests will be made : MoCA, FAB, TMT, Stroop-Victoria, JAT; Diagnostic test: Functional RMI; With specific test of decision making (IGT) specially adapted to the population; Diagnostic test: High Resolution EEG; With specific test of decision making (BART) specially adapted to the population; Other: Qualitative interview; Qualitative semi-directed interviews with participants, their caregivers and their geriatrician to analyse everyday life decision making ability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of concordance/disordance between the standardized global gerontological evaluation and the objectification of the activation zones of prefrontal ventromedial and dorsolateral cortex by functional imaging	The cohort data will be compared between patients identified as " questionable ability " according to the clinical evaluation (reference) and the neuroimaging evaluation, in order to see if the imaging allows to reclassify patients as " able ". A 10 % diagnostic gain in expected. Concerning functional neuroimaging (Balloon Analog Risk Task): The lack of activation of specific brain areas during period of interest will be considered as "compatible with the ability to make decisions" on neuro-functional imaging, while patients who do not activate the ROIs in the same situation will be considered as "compatible with questionable decision-making ability". Concerning standardized geriatric assessment: At the end of the initial consultation, based on his clinical examination, interview and standardized neuropsychological assessment, the geriatrician will classify each patient either as " preserved decision-making ability " or " questionable decision-making ability ".	1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between neuropsychological test and neurofunctional imaging	The results of the functional neuroimaging tests will be analyzed in comparison with the neuropsychological tests performed, to verify the correlation between the results of the neuropsychological tests of decision-making ability and the results of the neuroimaging tests, and thus to identify, among the battery of tests used, those that are the most discriminating in the evaluation of decision-making ability	1 day
Comparison between neurocognitive disorders stage and decision-making ability	The neuropsychological tests that will be carried out will allow to identify the stage of neurocognitive disorders in patients. These elements can be correlated with the analysis of decision-making abilities in order to demonstrate a correlation between neurocognitive disorders, their stage, and decision-making ability	1 day
Analysis of the implication of the decision-making ability in everyday life situation	Based on the semi-directed interviews, a qualitative analysis will be carried out to study the reality of everyday life situations where decision-making ability is mobilized. A particular focus will be made on the impact of neurocognitive disorders on aging in place, and thus on the decision to integrate a nursing home.	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: Université de Montréal
• Investigators: Study Chair: Regis AUBRY, PhD, Centre Hospitalier Universitaire de Besançon

Publications and helpful links

General Publications

• Tannou T, Godard-Marceau A, Joubert S, Daneault S, Kergoat MJ, Magnin E, Comte A, Gabriel D, Vidal C, Pazart L, Aubry R. Added value of functional neuroimaging to assess decision-making capacity of older adults with neurocognitive disorders: protocol for a prospective, monocentric, single-arm study (IMAGISION). BMJ Open. 2021 Sep 29;11(9):e053549. doi: 10.1136/bmjopen-2021-053549.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Dementia; Aging; Neuropsychology; Decision making; Neuroimaging
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Neurocognitive Disorders
• Other Study ID Numbers: API/2018/100; API3A2018 (Other Grant/Funding Number: CHU de Besancon); Don Du Souffle 2018 (Other Grant/Funding Number: Don du Souffle Besancon); Prix H Mutuelle Alzheimer 2019 (Other Grant/Funding Number: Harmonie Mutuelle - Fondation de l'Avenir)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No